Mondaq August 15, 2023
Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the point that they themselves are now classified as medical devices and referred to as Software as a Medical Device (SaMD).
These software-based interventions are expected to expand patient access, improve physician workflow, reduce payor costs, and improve clinical outcomes for patients. However, the introduction of SaMD and other digital therapeutic technologies into the health care system raises unique regulatory questions in their implementation and commercialization.
In this fifth installment of this blog series on SaMD, we discuss (1) reimbursement challenges; and (2) state regulatory considerations/challenges applicable to companies offering SaMD...
Today's Sponsors
Today's Sponsor